Navigation Links
Celtaxsys Begins US Enrollment for Phase 2 Trial of Acebilustat Anti-Inflammatory Therapy for Cystic Fibrosis
Date:10/8/2015

ATLANTA, Oct. 8, 2015 /PRNewswire/ -- Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from orphan inflammatory diseases, announced today the commencement of the US arm of an international phase 2 clinical trial for its flagship compound, acebilustat, in patients with cystic fibrosis (CF). The study will be conducted at approximately 60 sites in the United States and European Union, with the EU sites anticipated to begin enrollment early 2016. This landmark clinical trial testing once-daily oral acebilustat treatment over 48 weeks could be the first to establish proof-of-concept for an anti-inflammatory treatment specifically designed to prevent long-term loss of lung function in CF patients. The study will test once daily oral doses of 50 mg and 100 mg acebilustat against placebo on top of background therapy in adult CF patients.

Acebilustat is a first-in-class neutrophil modulator that controls a key inflammatory signal overexpressed in CF and other orphan inflammatory diseases. Acebilustat has been granted orphan drug status for the treatment of CF in the US and the EU.  Results from initial clinical studies in CF patients demonstrated acebilustat's ability to moderate the over-activated inflammatory response in CF, decreasing neutrophils in the lung by 65% and decreasing damaging neutrophil elastase in just two weeks of treatment. Acebilustat did this without jeopardizing the patient's immune response to infection. Importantly, acebilustat treatment is applicable to all CF patients irrespective of their gene mutation and can be used on top of background therapy, including Kalydeco and Orkambi.

The Phase 2 CF trial was designed in conjunction with and supported by a grant from Cystic Fibrosis Foundation Therapies, Inc. (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. It will include approximately 30 sites in the US under the oversight of Principal Investigator Dr. Stephen Rowe MD MSPH, Professor at the University of Alabama Birmingham School of Medicine, Director of the Cystic Fibrosis Transition Clinic, and Director of the CFFT Development Network Center for CFTR Detection. Said Dr. Rowe, "CF patients are in desperate need of efficacious and safe anti-inflammatory therapies to control progressive lung disease.  Evaluation of the long term effects of acebilustat is a very important step in that direction, given the favorable Phase 1b results in CF patients."

For more information, please visit http://clinicaltrials.gov/show/NCT02443688.

Logo - http://photos.prnewswire.com/prnh/20150605/221207LOGO


'/>"/>
SOURCE Celtaxsys, Inc.
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. Celtaxsys, Inc. Gains FDA Clearance for Landmark Phase 2 Trial of Anti-Inflammatory Treatment for Cystic Fibrosis (CF)
2. Celtaxsys Has Regulatory Clearance to Begin Phase 2 Trial of Oral CTX-4430 Anti-Inflammatory Therapy for Moderate to Severe Acne Vulgaris - Recruitment of Patients to Commence Immediately
3. Celtaxsys Announces Sanjeev Ahuja as Chief Medical Officer
4. Greg Duncan Appointed President and Chief Executive Officer of Celtaxsys, Inc.
5. Celtaxsys Announces Successful Completion of Phase 1 Clinical Trial for Development of CTX-4430
6. Celtaxsys Restructures, Enhances Operational Focus
7. Construction Begins at Genovate Biotechnologys Insulin Ecological Industrial Park in Chinas Changzhou National Hi-tech District
8. NOWDiagnostics Inc. Begins Manufacturing New Point-of-Care Tests Capable of Providing Results in Just Minutes with the Same Reliability as Lab-Based Tests
9. Worlds Most Technologically Advanced Cannabis Cultivation Facility And Laboratory Begins Operating In Delavan, Illinois
10. GSK begins shipping 2015-16 US flu vaccines with focus on customer needs, volume, and speed
11. Aethlon Medical Begins Trading on the Nasdaq Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... 2017 OBP Medical , a ... devices, today announced regulatory approval from ... Agência Nacional de Vigilância Sanitária (ANVISA)) to market ... retractor with integrated LED light source and smoke ... exposure of a tissue pocket or cavity during ...
(Date:10/2/2017)... Fla. , Oct. 2, 2017  AllianceRx Walgreens ... company formed by Walgreens and pharmacy benefit manager Prime ... its new brand, which included the unveiling of new ... , as well as at a few other ... the new brand to patients, some of whom will ...
(Date:9/28/2017)... Hill-Rom Holdings, Inc. (NYSE: HRC), will host ... webcast on Friday, November 3, 2017, beginning at 7:00 ... approximately 8:30 a.m. (CDT) / 9:30 a.m. (EDT). ... performance and guidance for 2018, Hill-Rom executives will also ... performance, and long-range financial outlook through 2020. ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... , ... Talented host, actor Rob Lowe, is introducing a ... episode of "Success Files," which is an award-winning educational program broadcasted on PBS ... in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve in ...
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
(Date:10/12/2017)... Fla. (PRWEB) , ... October 12, 2017 , ... IsoComforter, ... therapy products, announced today the introduction of an innovative new design of the shoulder ... pad so you get maximum comfort while controlling your pain while using cold therapy. ...
(Date:10/12/2017)... ... October 12, 2017 , ... Dr. Parsa Mohebi, the ... medical article to the newly revamped Cosmetic Town journal section, featuring ... transplant procedure known as Follicular Unit Extraction (FUE). , Dr. Mohebi ...
(Date:10/12/2017)... RAPIDS, Mich. (PRWEB) , ... October 12, 2017 ... ... Wellness, has been named one of Michigan’s 2017 Best and Brightest in Wellness® ... and Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. ...
Breaking Medicine News(10 mins):